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NCT01521455 Clinical Trial

Therapeutic Equivalence Study of HCP0910 250/50 Mcg to Seretide 250 Diskus in Asthmatic Patients

Asthma Clinical Trial

Official title:
A Phase I, Randomized, Open, Multi-center, Cross Over Study to Evaluate the Therapeutic Equivalence of Repeated Dose of HCP0910 250/50 μg to SeretideTM 250 DiskusTM in Asthmatic Patients

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01521455
Other study ID # HM-FTOL-101
Secondary ID
Status Completed
Phase Phase 1
First received January 26, 2012
Last updated August 22, 2013
Start date February 2012
Est. completion date July 2013

Study information
Verified date August 2013
Source Hanmi Pharmaceutical Company Limited
Contact n/a
Is FDA regulated No
Health authority Korea: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The purpose of this study is to prove that HCP0910 is therapeutically equivalent to Seretide 250 Diskus when repeatedly dosed to Asthmatic patients.

Recruitment information / eligibility
Status Completed
Enrollment 56
Est. completion date July 2013
Est. primary completion date June 2013
Accepts healthy volunteers No
Gender Both
Age group 20 Years to 75 Years
Eligibility Inclusion Criteria:

- age 20 ~ 75 inclusive

- Asthmatic diagnosis in more than 12 weeks from screening day

- Shows more than 12 % increase, and 200mL increase in FEV1 measure on Visit 2

Exclusion Criteria:

- Maintain controlled asthma for more than 4 weeks before screening

- Diagnosed as a severe asthmatic patients

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• HCP0910
250/50, BID for 2 weeks
• Seretide Diskus
250/50, BID for 2 weeks

Locations
Country Name City State
Korea, Republic of Soon Chun Hyang University Hospital Bucheon Bucheon Gyunggi -do
Korea, Republic of Asan Medical Center Seoul
Korea, Republic of Ewha Womans University Medical Center Seoul
Korea, Republic of Hanyang University Hospital Seoul
Korea, Republic of Samsung medical center Seoul
Korea, Republic of Seoul National University Seoul
Korea, Republic of Ajou University Hospital Suwon Gyunggi -do

Sponsors (1)
Lead Sponsor Collaborator
Hanmi Pharmaceutical Company Limited

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary mean change of morning predose FEV1 from baseline day 14 No
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